• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM; ROD, 6MM, STRAIGHT, LENGTH 45MM,

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ULRICH GMBH AND CO. KG UCENTUM; ROD, 6MM, STRAIGHT, LENGTH 45MM, Back to Search Results
Model Number CS 3807-045
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 02/07/2024
Event Type  Injury  
Event Description
A few weeks following the surgical procedure, it was discovered that a rod was fractured.A revision surgery was required to replace it.Cause of the fracture is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UCENTUM
Type of Device
ROD, 6MM, STRAIGHT, LENGTH 45MM,
Manufacturer (Section D)
ULRICH GMBH AND CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM  89081
MDR Report Key18822786
MDR Text Key336734520
Report Number3005823819-2024-00003
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCS 3807-045
Device Catalogue NumberCS 3807-045
Device Lot NumberU038012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/01/2024
Device Age1 YR
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/01/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age83 YR
Patient SexMale
Patient Weight120 KG
-
-